NCT05376904已完成2 期
A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Controlled Study to Evaluate the Efficacy and Safety of Local Administration of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 18
- 主要终点
- AUC of Pain Intensity in rest state
研究概览
简要总结
The study is being conducted to evaluate the efficacy, and safety of HR18034 for postoperative analgesia in subjects undergoing hemorrhoidectomy. To explore the reasonable dosage of HR18034 for postoperative analgesia in subjects undergoing hemorrhoidectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide a written informed consent
- •Subjects requiring hemorrhoidectomy under subarachnoid anesthesia
- •18 kg/m2 ≤ BMI ≤ 28 kg/m2
- •Conform to the ASA Physical Status Classification
- •Women of childbearing age have a negative pregnancy test and are not nursing
排除标准
- •Subjects with a history of myocardial infarction or unstable angina pectoris
- •Subjects with atrioventricular block or cardiac insufficiency
- •Subjects with a history of ischemic stroke or transient ischemic attack
- •Subjects with a history of mental illness and a history of cognitive impairment epilepsy
- •Subjects with concurrent painful physical condition that may affect postoperative pain assessment
- •Subjects with myelopathy or spinal disease
- •Subjects with a history of hemorrhoidectomy
- •Abnormal values in the laboratory
- •Subject with a history of substance abuse and drug abuse
- •Subject with refractory hypertension
- •History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics, opioids, or other drugs that may used in study
- •History of substance abuse, drug use and/or alcohol abuse
- •HBsAg, HCVAb, HIV antibody and syphilis antibody tested positive during screening period;
- •Participated in clinical trials of other drugs (received experimental drugs)
- •The inestigators determined that other conditions were inappropriate for participation in this clinical trial
研究组 & 干预措施
HR18034 dose 1
Experimental
干预措施: HR18034 (Drug)
HR18034 dose 2
Experimental
干预措施: HR18034 (Drug)
HR18034 dose 3
Experimental
干预措施: HR18034 (Drug)
ropivacaine HCl
Active Comparator
干预措施: ropivacaine HCl. (Drug)
结局指标
主要结局
AUC of Pain Intensity in rest state
时间窗: 0~72 hours after administration
Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 72 hours.
次要结局
- Investigator's satisfaction score for analgesia treatment(72-hours)
- AUC of Pain Intensity in rest state(0~24 hours，0~48 hours after administration)
- Pain intensity in move state assessed using an 11-point NPRS ranging(0~72 hours after administration)
- Participant's satisfaction score for analgesia treatment(72-hours)
- AUC of Pain Intensity in move state(0~24 hours，0~48 hours，0~72 hours after administration)
- Pain intensity in rest state assessed using an 11-point NPRS ranging(0~72 hours after administration)
- Proportion of subjects who doesn't recive rescue analgesic(0~72 hours after administration)
研究者
研究点 (18)
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